Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor

NCT03518138 | Completed Phase 2 FDA Drug

• 1 other identifier: Q122-2001
• Study Type: interventional
• Target: 132
• Locations: 3 countries
• Sites: 18

Brief Summary

This is a Phase 2 proof-of-concept (POC) study designed to determine the effectiveness of Q-122 for the treatment of Vasomotor Symptoms (VMS) versus placebo. Participants who meet all eligibility criteria following the Screening/Run-In period will be randomized to 1 of 2 treatment arms; blinded Q-122 or placebo for a period of 28 days. All participants will be followed for a 2-week, drug-free, follow-up period after their last dose of blinded Q-122/placebo before termination from the study.

Conditions

Vasomotor Symptoms (VMS)

Outcome Measures

Primary Outcomes (1)

• Hot Flash Severity Score (HFSS)

  The primary efficacy outcome measure will be the change from baseline in the HFSS for moderate and severe hot flashes (HFSS-m/s) calculated for each treatment week by multiplying the severity by the frequency using the following formula: (2 x number of moderate) + (3 x number of severe)

  4 weeks

Study Arms (2)

Group 1, study drug

EXPERIMENTAL

65 patients treated with Q-122, 100 mg BID

Drug: Q-122

Group 2, placebo

PLACEBO COMPARATOR

65 patients treated with placebo

Drug: Placebo

Interventions

Q-122 DRUG

oral capsule of Q-122

Group 1, study drug

Placebo DRUG

oral capsule of placebo

Group 2, placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a female, aged between 18 - 70 years on the day of informed consent.
• Have a history of or current breast cancer and currently taking tamoxifen or an aromatase inhibitor.
• On a stable dose of TAM or an AI for a minimum of 30 days before the Screening Visit and no anticipated need to change the dose for the duration of the study.
• Experience an average of at least 50 moderate to severe hot flashes/week for the 2 weeks immediately preceding the Run-In Visit (i.e., during the Screening period).
• If on thyroid medication, on a stable dose for a minimum of 30 days before the Screening Visit and no anticipated need to change the dose for the duration of the study.
• Willing and able to complete the daily participant diary, attend all study visits, and participate in all study procedures.
• Able to provide informed consent.

You may not qualify if:

• Childbearing potential, pregnancy, or lactation except in patients who are on stable dose of AI in combination with luteinizing hormone releasing hormone agonists such as Zoladex, Leuprolide (Lupron) or equivalent. Non-childbearing potential is defined as physiologically incapable of becoming pregnant by one of the following:
• Has had a partial or complete hysterectomy or
• Has had a bilateral oophorectomy or
• Has had a bilateral tubal ligation or fallopian tube inserts or
• Is post-menopausal (amenorrhea \> 1 year) confirmed by levels of follicle stimulating hormone (FSH). FSH levels may be lower in menopausal women treated with tamoxifen when compared with FSH levels appropriate for confirming menopause in women not treated with tamoxifen. For those patients who are on stable dose of tamoxifen, confirmation of menopause is based on the clinical opinion of the PI and medical monitor on a 'case-by-case basis'.
• Currently experiencing undiagnosed vaginal bleeding.
• Women with advanced breast cancer (Stage 4).
• Greater than 60% reduction in the frequency of moderate to severe hot flashes during the 1-week single blind Run-In period or inability to correctly record hot flashes and/or drug dosing in the participant diary.
• Participation in another clinical or surgical trial within 30 days prior to screening or during the study without the prior written consent of the Medical Monitor.
• Gastrointestinal, liver, kidney or other conditions which could interfere with the absorption, distribution, metabolism or excretion of Q-122 at PI discretion.
• Untreated overt hyperthyroidism.
• Have any other medical condition, clinically important systemic disease or significant co-morbidities or any finding during Screening that in the judgment of the investigator puts the participant at increased risk by participation in this study, or that may affect the reliability of participant diary entries.
• Known inability to complete all study visits and study assessments for scheduling or other reasons.
• BMI \> 40 kg/m2; Participants with a BMI greater than 40 kg/m2 may be enrolled on a case-by-case basis if approved by the Medical Monitor and if the participant is not deemed at increased risk of adverse effects based on body habitus and cardiovascular health.
• Women with a history of, or current evidence of, abuse of alcohol or any drug substance, or who regularly drink more than 3 standard drinks per day.

Sponsors & Collaborators

• Que Oncology: lead
• Syneos Health: collaborator

Study Sites (18)

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

Location

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

Location

John Hopkins

Baltimore, Maryland, 21287, United States

Location

Brighams and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Baylor Scoot & White Medical Center

Temple, Texas, 76508, United States

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

ICON Group, Icon Cancer Care Wesley

Brisbane, 4066, Australia

Location

School of Public Health and Preventive Medicine, Monash University

Melbourne, 3004, Australia

Location

The Royal Women's Hospital

Melbourne, 3052, Australia

Location

Keogh Institute for Medical Research

Perth, 6009, Australia

Location

Women's Health Research Institute of Australia

Sydney, 2000, Australia

Location

Royal North Shore Hospital

Sydney, 2065, Australia

Location

Optimal Clinical Trials

Auckland, 1010, New Zealand

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Christchurch Clinical Studies Trust Ltd

Christchurch, 8011, New Zealand

Location

P3 Research - Hawkes Bay

Havelock North, 4130, New Zealand

Location

P3 Research - Tauranga

Tauranga, 3110, New Zealand

Location

Related Publications (1)

• Vrselja A, Latifi A, Baber RJ, Stuckey BGA, Walker MG, Stearns V, Hickey M, Davis SR. Q-122 as a novel, non-hormonal, oral treatment for vasomotor symptoms in women taking tamoxifen or an aromatase inhibitor after breast cancer: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2022 Nov 12;400(10364):1704-1711. doi: 10.1016/S0140-6736(22)01977-8.

  PMID: 36366886 DERIVED

MeSH Terms

Interventions

N,N'-(1,4-phenylenebis(methylene))dipyrimidin-2-amine

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 8, 2018
• Study Start: October 24, 2018
• Primary Completion: July 29, 2020
• Study Completion: September 9, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

US (6); AU (7); NZ (5)